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EU probiotics regulation

A grasp on EU probiotics regulation

Published on: 3/26/2010
Author/s : Lallemand
FEFANA (EU Feed Additives and Premixtures Association) in partnership with its French platform SYNPA (Syndicat national des producteurs d'additifs et d'ingrédients de la chaîne alimentaire) recently held a press conference about probiotics as feed additives at the Maison de la Meunerie in Paris. This meeting was an opportunity to focus on the evolution of the European regulations concerning feed additives and more particularly probiotics. The press conference is one of the actions initiated by the FEFANA working group in charge of communicating about probiotics, gathering the main producers of probiotic bacteria and yeasts in Europe, and chaired by Pascal Raoul, Lallemand Animal Nutrition General Manager. The role of this working group is not only to promote benefits of probiotics in feed but also to address technical issues linked with their usage as well as to share this information with other professionals.
Feed Additives: a strict regulatory frame.
Probiotics, essentially live bacteria or yeast, are authorized in Europe as zootechnical additives. Since 1993, they have therefore followed a very strict regulation which makes provision for scientific assessment by a committee of experts during which manufacturers shall produce evidence of the identity, safety and efficacy of their product. When this assessment is positive, the relevant product receives an authorization fixing very specific usage and labeling conditions, particularly as far as product claims are concerned, under Regulation (EC) No 1831/2003 on feed additives. This process provides a guarantee of the safety, traceability and efficacy of the probiotics entering the feed and food chain.
A function-based classification
The classification of additives according to Regulation (EC) No 1831/2003 is based on their functionality and not on their composition.
As mentioned by Didier Jans, Secretary General of FEFANA, five categories have been defined. These categories are also divided into functional groups which correspond to very precise claims:
1. Technological additives:
  • * Preservatives,
  • * Emulsifiers,
  • * Stabilizers,
  • * Acidity correctors,
  • * Silage additives
2. Sensory additives:
  • * Colorings,
  • * Aromatic substance
3.: Nutritional additives:
  • * Vitamins,
  • * Trace elements,
  • * Amino acids,
  • * Urea...
4. Zootechnical additives
  • * Digestibility enhancers,
  • * Gut flora stabilizers,
  • * Substances which favorably affect the environment...
5. Coccidiostats/histomonostats.
Some specific authorization criteria concerning identity/quality, safety and efficacy apply to each category.
The registration dossier : a seal of quality, safety and efficacy
Professor Michel Larbier, Honorary Research Director at INRA, the French Agronomic Research Institute, presented the main steps of feed additive registration in Europe.
The dossier, compiled by the manufacturer, shall be composed of three main sections (see text frame). Dossier construction can take several years, to which more years for basic product development must be added (selection, characterization of one specific microorganism strain among thousands of natural strains, development of the production process, as far as microorganisms for probiotics or silage additives are concerned).
The European Commission passes the dossier to EFSA (European Food Safety Authority) which relies on a specialized experts panel (FEEDAP) for its scientific assessment. For each section of the dossier, methodology and validity of results are assessed. Proposed claims are verified against the presented results on efficacy. If questions are raised during the assessment, the manufacturer is required to answer them. EFSA, which has a strictly consultative role, releases a scientific opinion, after which the dossier is submitted for the vote by the 27 Member States.
Upon receiving the dossier from the Commission, EFSA has three months to verify its content, then the assessment period is limited to a maximum of six months if no question is raised, while each question can "stop" the clock.
Additive or raw material?
Mrs. Catherine Evrevin of the DGCCRF (the French General Directorate for Competition Policy, Consumer affairs and Fraud Control) indicated that additives follow the principle of the positive list, and only those for which evidence of identity, quality, safety and efficacy are provided are registered and authorized under specific usage conditions (dosage, target animal species, physiological stage, ...). On the other hand, feed raw materials follow a principle of free circulation provided that they do not represent any risk (existence of a negative list).
Unlike raw materials which cannot make functional claims, authorized additives can have clear demonstrated and approved claims on the performance, welfare or environment of the animal.
 The three sections of a European registration dossier applying to probiotics
  • 1- Identity and quality: strain characteristics (taxonomy, metabolism, properties...), manufacturing process, stability (on its own or in mixture), method of analysis.
  • 2- Safety: for the target animal species (harmless at 10 times the recommended dose), the handler, the consumer (lack of antibioresisance, genotoxicity and mutagenicity) and the environment.
  • 3- Efficacy: to be demonstrated for the target species through at least three significant studies in two different locations. The efficacy section describes the target species, the conditions (age, physiological stage, type of production), the usage doses, the claimed performances as well as the possible action mechanisms.
The possible claims for probiotics can be effects on animal performance, production, welfare or environment.
Confusion may arise between raw materials and additives, as illustrated by Professor Jouany, also from INRA, in his presentation about the effects and modes of action of probiotics in animal nutrition. He explained the difference between inactivated yeast, used as raw material, and probiotic yeast. While the former are used as a source of nutriments, the latter exert zootechnical effects linked to their biological activity in the animal digestive tract.
In order to help manufacturers and users clearly identify different categories of products, a new regulation was voted by the European Parliament at first reading on February 9th, 2009. The text will be soon adopted by the Council. This new regulation aims at clarifying the definition of raw materials, with the possibility of allocating some nutritional claims to them. It will lead to the creation of a Community catalogue of raw materials and a Community code of good practices for labeling of composed feed which will regulate the demonstration and the usage of any claims. Catherine Evrevin also said that this regulation, which "is an additional step towards harmonization for products which are in a 'grey' zone", has been set for more transparency and traceability for users, "from farm to fork". The new regulation also makes provisions for the set up of a helpful decision tool regarding additives, raw materials and medicines. Thereon, Didier Jans explained that FEFANA took a lead as the association already offers "ID-feed", an online tool which allows the identification of the regulatory status of any individual product or mixture in animal nutrition.
Lallemand's authorized feed additives
At Lallemand Animal Nutrition, we put
a lot of efforts towards the registration
of our probiotics and silage additives.
Here is a summary of the regulatory  status of our ruminant and monogastric ranges.   
Levucell® SC20 and Levucell SC® 10ME (S . cerivisiae CNCM I-1077) are authorized in bovine destined to the production of milk and meat, dairy small ruminants (sheep and goat) as well as fattening lamb (authorization N° E1711/4b1711). An equine authorization is being assessed by the Commission.
Bactocell® (Pediococcus acidilactici MA 18/5M) is authorized for fattening pig under authorization number E1712.
Levucell® SB (Saccharomyces cerevisiae boulardii I-1079) is authorized for piglet and sow (authorization N° E1703).
Bactocell® (Pediococcus acidilactici MA 18/5M) is authorized for broiler chicken (authorization N° E1712).
Bactocell® (Pediococcus acidilactici MA 18/5M)  is being assessed by the Commission for use in shrimp and fish.
Silage additives
The specific microbial strains that constitute the active ingredients of the Lalsil® range of forage-specific silage inoculants (Lalsil® CL, Lalsil® PS, Lalsil® Dry, Lalsil® MS01 and Lalsil® Fresh) have been notified to the Community register of feed additives in 2005. Under European regulation 1831/2003, products listed on the Register are authorised until November 2010, when a new authorisation will have to be filed for a ten years period.
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